FDA Approval for MRI Labeling on ReActiv8® Restorative Neurostimulation System™
DUBLIN–(BUSINESS WIRE)– Mainstay Medical Holdings plc today announced that the U.S. Food and Drug Administration (FDA) has approved full-body MRI conditional labeling for the ReActiv8® Restorative Neurostimulation system. This approval applies to all current and future ReActiv8 patients in the United States implanted with the current 45 cm commercially-available leads.
The approval provides patients implanted with ReActiv8 the ability to undergo 1.5T full-body MRI scans. Specific scan conditions and safety information are provided in the ReActiv8 FDA MRI Guidelines manual.
“This approval expands the existing safety profile of ReActiv8, broadening access to patients who may need (or develop the need) for MRI imaging after implant,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical. “The ReActiv8 MRI labeling is one of the most comprehensive among neurostimulation devices approved for chronic low back pain, with full-body imaging at 1.5T at normal operating mode (maximum specific absorption rate (SAR) of 3.2 W/kg for the head and 2.0 W/kg for the rest of the body). We look forward to building on this as we seek conditional MRI compatibility in Europe and Australia.”
